FDA Says Dozens Given Nonsterile Simulated Saline

The U.S. Food and Drug Administration said last month that more than 40 patients had received infusions of intravenous simulated saline from bags made by Wallcur LLC that wasn’t sterile or intended for human use. Some patients were hospitalized. There has been at least one death linked with using the products. Adverse reactions associated with the simulated saline include fever, chills, tremors and headaches, the FDA said in a statement. The agency said it wasn’t clear that the reported death associated with the simulated saline was directly related to its use.

The simulated saline IV bags manufactured by Wallcur, which are only meant to be used in training, simulation and education, aren’t sterile and shouldn’t be used in humans or animals, according to the agency. “Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients,” the FDA said.

On Dec. 30, the FDA said that it was investigating use of Wallcur’s simulated saline solution bags after reports of adverse events linked with them in Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado. The solution was sent to medical clinics, surgical centers and urgent care facilities in the states, according to the FDA. On Jan. 7, San Diego-based Wallcur recalled all four sizes of its Practi-0.9% sodium chloride IV bags and its Practi-0.9% sodium chloride 100 ml IV solution bag with sterile distilled water, saying in a statement that the bags had been administered to patients even though they were intended “for clinical simulation” only.

In its recall notification letter, Wallcur advised consumers to quarantine the simulated saline products and return them to the company. The company also provided labels for the IV bags to make them easier to identify and said it planned to add similar labels to the bags before distributing them in future. Wallcur began shipping the simulated saline IV bags in May 2014, the company said. Patients who received the simulated IV saline almost immediately experienced symptoms such as fever and headache, which were recognized and treated promptly in most cases, the FDA noted.

The agency added that supplies of normal intravenous saline have been tight and that it didn’t object to the temporary distribution of additional normal saline from the alternate source companies, Fresenius Kabi USA, Baxter Healthcare Corp. and B. Braun Medical Inc. The FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate the use of the Wallcur products, the agency said.